Whilst researching Hudson’s GSK career on the web I came across these two very interesting articles. Since this blog was set up 6 years ago in order to document the Seroxat Scandal- and all that it entails -it seems Ian Hudson might be a major player in unravelling the truth about Seroxat- therefore some coverage of him is entirely warranted.

I would realy like to know what he knows about Seroxat… What was his role at GSK? Did it involve Seroxat? Does he know what GSK have hidden in their Seroxat files? As the previous head of “Global Safety” at GSK and now the guy responsible for safe-guarding the UK public from potentially harmful drugs such as Seroxat and Avandia how does Ian Hudson reconcile his conscience when a drug he once defended has been proven to kill?

Does Ian Hudson still take the stance of his previous employers (GSK) in regards to Seroxat efficacy and safety? It was- after all- way back in 2001 when Ian Hudson defended Seroxat (Paxil) in a case where GSK were found guilty. Since that time- there have been numerous settlements involving Paxil withdrawal cases, suicides and birth defect class actions in the US. There have been petitions, documentaries, web-sites, patient groups and media coverage on the dangers of Seroxat/Paxil and much public outcry about the behavior of GSK (Ian Hudsons previous paymasters). Since 2001, GSK have paid Billions in fines, and been found guilty of numerous crimes of fraud and corruption – crimes and lies which have cost patients their lives. I wonder does Ian Hudson still stand by the credibility of GSK now- in light of their current reputation? Does he still believe their word is trustworthy?…

What was his role in all of this way back when he was working for GSK defending Seroxat in court cases in the US? As CEO of the medicines regulator, is he on the side of patients or the pharmaceutical industry?

A City MP is demanding to know why the UK is being represented in a European review of the antidepressant drug Seroxat by a man who used to work for GlaxoSmithKline (GSK).

Parmjit Dhanda, MP for Gloucester, is asking the Government why they allowed Dr Ian Hudson to take part in the European Medicines Evaluation Agency (EMEA)’s review of Seroxat. As well as working as worldwide safety director for GSK – the manufacturers of Seroxat – from 1999 until 2001, Dr Hudson acted as witness for the defence in a trial in which Seroxat was accused of triggering a man’s violent and suicidal behaviour.

But the Government’s Medicines and Healthcare Products Regulatory Agency (MHRA) says it is satisfied Dr Hudson’s previous links with GSK will not compromise the review.

They say he will not be allowed to participate in Seroxat discussions during the review.

Mr Dhanda said: “I am really determined to get to the bottom of this.

“We need to make people aware that there are representatives involved in this inquiry into the drug who have worked with GSK in the past.

“Secondly, we have got to change this completely and we need to get some fully independent people involved.”

Mr Dhanda yesterday tabled four questions in the House of Commons demanding answers from the Secretary of State for Health, John Reid.

Earlier this year, a UK review into Seroxat was disbanded after it emerged many of the members held interests in GSK.

Alongside another representative from the MHRA, Dr Peter Arlett, Dr Hudson is part of a team of 30 experts from across Europe who are evaluating the safety of Seroxat following concerns raised in the UK and in the United States.

Noel Wadhion, head of the post-licensing of human medicines at the EMEA, told The Citizen: “We are looking at safety concerns relating to a potential risk of emotional changes and withdrawal reactions in the use of Paroxetine – the medical name for Seroxat.”

The experts, who began their review in June, hope to announce their results by the end of this year.

According to the EMEA, there are four possible recommendations to come as a result of their review – no action, change advice about the drug given to doctors, suspend the drug or withdraw it altogether.

Their recommendation will then be passed to the European Commission who will then make a final decision to be implemented throughout Europe.

GSK maintains that Seroxat – now the company’s best selling drug – is an effective treatment that has helped tens of millions of patients worldwide to lead fuller and more productive lives.

The appointment of Dr Hudson has angered Seroxat users in Gloucestershire who still hope for a full independent inquiry into the drug they claim has destroyed their lives.

Faye Elliott, spokeswoman for the Gloucestershire Seroxat Support Group, said: “Knowing that the European decision will be final, it is very worrying for the thousands of us who are still suffering with either side-effects or withdrawal symptoms from this drug.

“We would like to see this drug banned, as we believe there is enough evidence to suggest that this drug can cause suicidal ideation and self-harming.”

But the EMEA remain confident of its ability to reach a fair conclusion.

Mr Wadhion said: “We ask all members of our committee if there is any potential conflict of interest that we should be aware of.

“They must declare their interests before a debate can take place and must leave the room if a conflict arises.”

A spokesman for the MHRA said: “The Government actively encourages interchange between the Civil Service and industry, but takes care to ensure that there are no conflicts of interests.

“In line with this principle, Dr Hudson has had no involvement in matters relating to Seroxat since joining the agency and will have no involvement in the referral.”

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Burn in Hell

In my last post, Psychotic doubt, we saw the most successful maneuver that has ever been devised for hiding dead bodies and silencing us when we are injured. We saw a mechanism that acts like the authority of a psychoanalyst (when Freud was still in vogue), or an ecclesiastical authority (until recently), to silence dissent and cause someone who has been abused to doubt their sanity and blame themselves for something done to them. This mechanism that allows companies, regulators, and academics to hide dead bodies by an appeal to evidence that in actual fact shows an increased risk of death on treatment is not just psychosis-inducing; it also has a Burn in Hell component to it. This is how it happens. Here is Ronald Krall being deposed in 2007. He is the head of Global Safety at GlaxoSmithkline. Q: Are you willing to tell the jury under oath that you are not aware of a single side effect that is caused by Paxil? A: I am prepared to say to the jury that I am not sufficiently familiar with all of the data for all of the adverse events to tell you that there is an adverse event that is caused by Paxil.[1] Here is Ian Hudson being deposed in 2001, then head of Global Safety at GSK, later a member of the British regulatory apparatus, the MHRA:Q. Okay. So, your view is: It’s simply impossible for SmithKline Beecham to decide whether Paxil did or did not contribute to the homicidal or suicidal behavior of any one given individual; is that your testimony?A. We would certainly gather all the information, but on an individual case basis it would be impossible to decide whether paroxetine caused an event or not… It is impossible, on an individual case basis, from individual reports, to assign causality especially in a very complicated area such as this. That’s why, when we have issues, we review all the available data and make a determination, on the basis of all the available data, whether there is an issue or not.Q. Okay. Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?A: I have seen no evidence to suggest that at all.[2]If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance.Hudson and Krall are demonstrating the standard company approach to determining causality. In this case GSK had lots of reports of suicide, aggression, birth defects, or dependence. In many cases the doctor, or patient, or a company employee notes that the problem happened soon after the drug was started, cleared up when the drug was stopped, and reappeared when the drug was restarted. As a result in many cases a GSK employee has said the drug has caused the problem. Both men know this, but for Hudson and Krall there is still no evidence that their drug causes a problem — even when the dependence on Paxil (Seroxat) is universally recognized. Why not? For Hudson and Krall and regulators like Bob Temple or Ian Hudson (who is now a member of the British regulatory apparatus), if a clinical trial hasn’t confirmed a statistically significant link between treatment and an adverse event, then the adverse event hasn’t been shown to be caused by the treatment. If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance. The refusal to do a study while events pour in that meet all the standard criteria for causality is the real Burn in Hell moment. While the company avoids doing a sufficiently large clinical trial to test out the link, there will never be any evidence that the drug causes a problem. The refusal to do a study while events pour into the company that meet all the standard criteria for causality is the real Burn in Hell moment. Thousands of reports can pour in, each making a compelling case that the drug has caused the problem, but a Hudson or Krall or Temple will feel comfortable saying under oath they have seen no scientific evidence that the drug causes a problem.

Unbelievable though it will seem, lawyers for pharmaceutical companies have recently advised that company coding staff, when faced with convincing evidence a drug has caused a problem (that is, when a problem appears after the drug is started and clears when it is stopped and reappears when it is restarted), should not code this as caused by the drug as they have been doing.

Catch-22

When patients report problems to the company and ask if there is any evidence the drug might be contributing, they are commonly referred back to the doctor who has prescribed the drug — who will be faced with the scientific literature, which will say there is no evidence that the drug has caused the problem. When patients ask for evidence on a drug, they are referred back to their doctor — who will be faced with the literature, which will say there is no evidence that the drug has caused the problem. Here is an unknown woman in 2001 contacting GSK. She terminated her first pregnancy, after radiology showed the baby had a serious heart defect (truncus arteriosus) and would likely not survive. The response from GSK is as follows:

‘We are attaching a copy of our current product information for Paxil… Please review the section on USE DURING PREGNANCY.Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe because you physician knows your medical history, he or she is best suited to answer your questions. Our Drug Information department is available to answer any questions your physician or pharmacist may have about our products.

She responds:

‘This response is in regards to an email I sent you preciously [sic]. I was asking to see if you have any, or were in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out any information on women who were on Paxil during pregnancy and if they were able to have healthy babies. I am in no way insinuating your product did this to my child. I love the product and don’t think that I could have gotten through my panic attacks without the wonderful help of this miracle drug. I just want to get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her. Please, if you do not have information, where is this information held? Does anyone do studies like this? Please any information that you may give me would be great’.

The birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this. In internal company documents, the birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this.

This seems eerily reminiscent of appeals by Catholic cardinals to Canon Law (an idiosyncratic take on legal significance) when asked to account for their handling of abuse cases in the Church.

Beefing up the Glaxo probe

THE Medicines and Healthcare products Regulatory Agency (MHRA) is one of those super regulators of which Labour is so fond.

But while many superwatchdogs like Ofcom appear to be hyperactive, the MHRA is earning a reputation for sleepiness and lack of transparency.

Nowhere has this been more obvious than in its recent dealings with GlaxoSmithKline.

To its credit, the agency moved with some speed a year ago to clamp down on the use of antidepressant Paxil/Seroxat by young people after it discovered potential suicide risks.

It also launched an investigation into why it had taken GSK so long to disclose a series of studies to regulators showing potential problems with Seroxat among young people.

One complication for the MHRA is that Dr Ian Hudson, currently director of licensing, was worldwide safety director for GSK until 2001. This potentially raised conflict of interest problems.

But until last week everything went quiet. That was when New York attorney general Eliot Spitzer launched his missile at GSK, accusing it of fraudulently suppressing research suggesting that the antidepressant was unsafe in treating young children.

The inquiries on both sides of the Atlantic are of a piece. Both focus on GSK’s methods and the way it presents data to the authorities, not on the substance of whether Paxil/Seroxat can be harmful in certain circumstances.

In fact, the problem is accepted by GSK which, in co- operation with the MHRA, sent out new instructions to medical practitioners last year.

A comparison could be made with Shell. The problem for the oil giant this year is not just that its reserves turned out to be less than it reported to the markets, but that bosses engaged in an elaborate cover-up to prevent this becoming public.

In the weekend press Jean-Pierre Garnier, GSK’s highly-paid, Philadelphia-based chief executive, fought back against Spitzer, accusing him of ‘bullying tactics’ and failing to alert GSK to what was coming.

It is interesting to note, however, that Garnier acknowledged that GSK’s research record has not been perfect.

Garnier and GSK cannot afford to ignore Spitzer. He is notably careful in preparing his cases and the Wall Street experience, where he brought to a head the market scandal, shows that he does not go on fishing expeditions. His cases are based mostly on hard evidence that walks through the door of his Manhattan office.

A settlement between Spitzer and GSK – if that is the route they take – could open the floodgates of compensation claims from the families of young Paxil/Seroxat users.

As important for the UK drugs industry is that the present cosy relationship between the MHRA and GSK – in which disputes rarely come into the open – is ended.

Moreover, the MHRA falls under the heavy hand of the Department of Health, which has little experience or apparent knowledge of cutting- edge commercial and pharmaceutical issues.

If it is to be an effective and trusted watchdog, the agency needs to be cut loose from government and the drugs industry. Nothing less will do to restore confidence in the approval process.

The riddle of the drug regulators

The resignation last night of Richard Brook, the chief executive of the mental health charity Mind, from an expert working group on antidepressants has prompted calls for a review of the system of regulating and licensing medical drugs.

Mr Brook was appointed as a lay member of the group, set up by the Committee on the Safety of Medicines last year for a thorough look at all the allegations against the antidepressant Seroxat, after years of patients’ and consumer groups’ concern about the side-effects of modern antidepressants. Some people say they cannot stop taking them, because withdrawal makes them feel so bad, others say the drugs have made them violent or suicidal.

On Thursday the CSM issued a warning to doctors about the appropriate dosage of Seroxat, a warning for which Mr Brook had been pressing in the light of trial data more than 14 years old which the CSM failed to consider in three successive reviews of the drug.

Mr Brook’s appointment was a departure from the CSM’s normal practices of drawing on a pool of scientists and drug experts who, with few exceptions, have or in the past had links with the drug companies, from shareholdings to research grants to their universities. All members have to declare their interests and either withdraw from the room or not vote when conflicts arise. Even so, there have been allegations of “institutional bias”.

The suggestion is that the regulating authorities and the drug companies are too closely interrelated. Key figures not only on the CSM but also in the Medicines and Healthcare Products Regulatory Agency – the drug licensing body which it advises – have a history of consultancy, research or even employment by pharmaceutical companies. Ian Hudson, for instance, the worldwide safety director of GlaxoSmithKline (GSK) until 2001, is now director of licensing at the MHRA.

The MHRA and CSM say that they have to draw on the expertise of a relatively small pool of highly qualified individuals who inevitably have gained their experience in the industry, but critics say it would be possible to find academics who are completely independent.

One of the fiercest critics, Charles Medawar of the consumer group Social Audit, will allege in a book to be published on Tuesday, Medicines Out of Control?, that the system is dangerously secretive, riddled with conflicts of interest, and indelibly flawed by chaotic and incompetent procedures for evaluating drug benefits and risks.

“These revelations [of the Seroxat trials] provide compelling evidence of the need for transparency in drug regulation. Had the evidence from these dose-ranging studies been made publicly available the regulators’ errors would have been apparent years ago,” he said.

Mr Medawar believes that there may be problems with the dosage of many other drugs, not only antidepressants. Eli Lilly, he points out, conducted a study of its own SSRI (selective serotonin reuptake inhibitor) drug Prozac in both 20mg and 5mg formulations. About 53% of patients responded satisfactorily to the low dose and 64% to the higher dose. Yet the 20mg tablet was licensed for everybody. “That means 50% of people are being exposed to four times the dose they need.”

Mr Medawar is one of those who are troubled by the revolving door between the drug regulators and the pharmaceutical industry. The MHRA chairman, Sir Alastair Breckenridge, resigned his position on Glaxo’s scientific advisory committee to take up his previous position as chairman of the CSM, although he has usually left the room when Seroxat has been discussed.

“For many years Breckenridge had close ties with the manufacturers of Seroxat, yet he played a key role in the regulation of that drug,” Mr Medawar said. While he was still on GSK’s advisory board Professor Breckenridge took part in the Seroxat licensing discussions, although he did not vote.

The data at the heart of the matter showed Seroxat to be ineffective and unsafe at high doses. An estimated 17,000 patients were put on doses higher than the recommended 20mg last year, according to the Department of Health. Seroxat is made by GSK in 20mg and 30mg tablets. But higher doses are no more effective than the 20mg pill, and carry the risk of increased side-effects.

The data on the drug comes from one of the original trials carried out to establish the effect and safety of different doses before GSK applied for a licence to sell it in 1990. Patients in the trial, which was conducted in 1985-86, were started on 10, 20, 30 or 40mg doses. Many of those on the higher doses dropped out because of the side-effects.

The MHRA and CSM were given this information by the company and they licensed it for depression, with 20mg as the recommended dose.

The MHRA, it is understood, did not employ statisticians at the time of the 1990 licence approval and must therefore have relied on GSK (then SmithKline Beecham) for an explanation of the data.

David Healy, director of the North Wales department of psychological medicine of the University of Wales, who claims that there is a suicide risk for a minority of patients on SSRIs, said: “This would look like a case of the MHRA taking what the company said. It’s only when they get pushed beyond a certain point that they begin to systematically check things out.”

Alastair Benbow, GSK’s head of European clinical psychiatry, said yesterday that GSK did not agree with the MHRA’s interpretation of the early study. He said the dosage study had been carried out in a way that would not be done today and that other studies, which had started patients on 20mg and then gradually increased the dose, should have been taken into account. Gradually increasing the dose was safe and some patients would benefit from taking doses of more than 20mg a day.

This is an industry that has succeeded in building a culture in which even good descriptions of the effects of drugs are dismissed as anecdotes – except of course for patients reporting stunning benefits on treatment.

An industry where Ian Hudson, then of GSK, now head of Britain’s FDA (MHRA), can get hundreds of reports of a problem like violence on Paxil-Seroxat and still say he has seen no evidence that Paxil-Seroxat causes any problems (See Burn in Hell).